Treatment effectiveness and patient safety

Risto Roine, M.D., Prof. University of Eastern Finland, Research Centre for Comparative Effectiveness and Patient Safety (Receps) [email protected]

Health care resources are limited • Strong pressure to increase health care spending •

ageing of the population

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new, usually expensive treatment methods

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new possibilities to treat diseases previously considered to be untreatable

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medicalization

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rising expectations concerning services

• At the same time, current recession is associated with difficulties to ensure even the current standard of care

Limitations also concerning workforce availability in the future 

In Finland 

16% of the total workforce works in health or social care



the mean age of this workforce is higher than in many other areas => much of the workforce will retire in the near future

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During the next ten years we will need from 20 000 (under optimal conditions) to up to 59 000 new employees to the health care sector

Infinite needs, limited resources • Administrative adjustments (the new Sote-law) will not alone solve the problem of resource scarcity • Prioritization is a necessity • Prioritization must be systematic, transparent, democratic, equitable • The primary basis for prioritization must be : • the relation of benefits to costs • this allows the healthcare sector to produce as much health as possible

The aim of health care is to maximize health gains • Effectiveness of care should be the principal criterion when choosing which treatments to offer and when planning activities – offering ineffective care is unethical and endangers patient safety – offering ineffective care is a waste of valuable resources

• Effectiveness is strongly related to patient safety

Institute of Medicine 1999, USA • To Err is Human –report – 44 000 - 98 000 deaths every year in US hospitals as a consequence of potentially avoidable adverse events – Adverse events cause more deaths than breast cancer or AIDS – Adverse events cause more deaths than traffic accidents

• The most common causes for adverse events are medication errors, infusion errors, errors associated with surgery, falls, burns, pressure ulcers, errors in patient identification • Adverse events cost 17-27 billion dollars per year

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In Finland • Of patients treated in hospitals • 1 in 10 faces an adverse event • 1 in 100 experiences a serious adverse event • 1 in 1000 dies or is left permanently disabled due to an adverse event

• 700-1700 deaths per year due to adverse events • Half of the adverse events could be avoided • by anticipating risks • by systematic monitoring of activities • by learning from past adverse events

• Costs related to adverse events in Finland at least 400 million euro/year 7

Cornerstones of patient safety • Promotion of safety culture • Harm reducing structures • Systematic and harm avoiding provision of care • Reactive learning from past adverse events • Continuous monitoring of treatment effectiveness

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Coverage of influenza vaccination in the Helsinki and Uusimaa Hospital District with approximately 21 000 employees 14000

100 HUS:n henkilökunnasta rokotetut (lukumäärä) HUS:n henkilökunnasta rokotetut (%-osuus)

12000

54 % 80

L u k u m ä ä r ä

48 %

10000

46 %

42 % 41 %

60 % o s u 40 u s

8000

28 %

6000

4000

14 %

20

2000

0

0 2003

2004

2005

2006

2007

2008

Pandemia 2009

2010

2011

2012

2013

A Successful Hospital-wide Improvement Work Reduced Healthcare-associated Infections – Increased compliance with hand hygiene routines – Prevention of urinary tract infections – A hospital-wide improvement ”school” • A large hospital wide campaign using multimodal strategies can reach a large part of the staff, change behaviour, increase knowledge and improve patient safety

Eva Joelsson-Alm, International Forum on Quality & Safety in Healthcare 2014

An important part of safety culture is the systematic provision of services • Surgical checklist • Care bundle approaches – Bundles of evidence-based practices •allow less individual freedom in provision of services, but •reduce infections and other harms

•Other examples •anticipation of nutritional problems of hospitalized patients •prevention of falls •prevention of pressure ulcers

Mean central line-associated bloodstream infection (CLABSI) rates

DePalo et al. Qual Saf Health Care 2010;19:555-61.

Bundle: hand-washing, full barrier precautions when inserting central access catheters, chlorhexidine skin-cleansing, avoiding the femoral site, removing unnecessary catheters.

Mean ventilator-associated pneumonia (VAP) rates and VAP bundle compliance

DePalo et al. Qual Saf Health Care 2010;19:555-61.

Bundle: daily assessment for liberation from mechanical ventilation, elevation of the head of the bed, appropriate sedation, deep venous thrombosis and gastric stress ulcer prophylaxes.

Five dimensions of safety measurement and monitoring

The measurement and monitoring of safety, © 2013 The Health Foundation

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Some examples of indicators in the different dimensions • Past harm • Hospital mortality

• 30-day mortality • Hospital acquired infections • Reliability

• Reliability of medical devices • ICT reliability • Patient identification

• Documentation • Sensitivity to operations • Safety walk-rounds • Weekly patient safety meetings 16

Some examples of indicators in the different dimensions • Anticipation and preparedness

• Surgical checklists • Risk registers • Patient safety culture • Integration and learning

• Monthly reporting • Dashboards for board of directors • Learning from past adverse events 17

OECD patient safety indicators

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AHRQ patient safety indicators

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Joint Commission Accountability Measures

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Effectiveness of care is a prerequisite of patient safety • If treatment is not effective, it cannot be safe either • all interventions are associated with potential risks • Information concerning effectiveness is needed for all interventions • Due to financial constraints information on costeffectiveness of care is also required • enables optimal and equitable distribution of resources

Terminology Term

Meaning

Answers the question

Efficacy

The efficacy of a treatment Can the treatment be effective under ideal conditions, usually under the most optimal within a randomized, controlled conditions? trial.

Effectiveness

The effect of a treatment under everyday health care conditions, e.g. in the hands of less skilled care providers (real world effectiveness).

Efficiency

The relation of the Is the treatment worthwhile? effectiveness of treatment to the costs needed to provide it.

Cost-effectiveness analysis

The effectiveness of treatment measured e.g. by life years gained or some other objective measures and related to the costs needed to produce them.

What is the most efficient way to use available resources?

Cost-utility analysis

The effectiveness of treatment is expressed as QALYs gained (which combine both the utility and length of life).

What is the most efficient way to use available resources?

Can the treatment be effective under normal health care conditions?

Randomized controlled trials • RCTs form the basis for choosing treatments – gold standard for efficacy • However, RCTs are also problematic – time-consuming and expensive – reflect optimal efficacy under best possible conditions

Systematic literature reviews and meta-analyses • Combine the results of single studies – can speed up the emergence of knowledge? – can take into account the sometimes contradictory findings of single studies • For literature reviews to be reliable, they need to be systematic – Cochrane – http://terveysportti.fi/ – HTA – http://lib-stakes.fi/ohtanen – HALO-ohjelma – www.thl.fi/halo – HOTUS – www.hotus.fi – Joanne Briggs –Institute • Even the best systematic literature reviews can not control the publication bias – positive results are more often reported

• Although RCTs are necessary when new treatment methods are introduced, they are not sufficient • We also need knowledge on the effectiveness of various treatments under usual health care conditions, i.e., data on their real-world effectiveness • Consequently collection and analysis of routine data is also necessary to ensure effectiveness of health care

Registers • All healthcare providers collect data into various registers • Despite that register-based data is underutilized for effectiveness analyses • Combining data from local and national registers would rapidly provide essential information concerning treatment effectiveness and patient safety • This is currently hindered by • cumbersome processes for gaining permission to use data • slowness of obtaining data • costs • scarce resources for register-based research

Health-related quality of life in the evaluation of effectiveness of secondary care The two main goals of health care are: • to keep a patient alive as long as possible • to maintain his/her subjective well-being (health-related quality of life) • The performance of health care can be measured by the change in: – length of life – quality of life • Both of them are combined in quality-adjusted life years (QALYs) – currently considered as the principal indicator of effectiveness of care by the British National Institute for Health and Clinical Excellence (NICE)

Routine follow-up of effectiveness of care • In HUS since 2002 effectiveness of care assessed with the 15D HRQoL-instrument and in some medical specialties with disease-specific measures – more than 15 000 patients – approx. 20 medical specialties – approx. 40 disease entities • Information on effectiveness combined with data on costs and organization of services to estimate cost-effectiveness of care (Ecomed-database) • Similar data collection now ongoing in KUH and in some other Finnish Hospital Districts

15D • Generic, 15-dimensional, standardised, selfadministered HRQoL instrument before and after treatment • 15D can be used both as a profile and a single index utility score measure • 15-dimensions, each one with five levels – the best level = 1; the worst level = 5

• Representative population control data available in Finland • Easy-to-use (self-administered) • Sensitive (discriminatory and responsive) • Compares favourably with other preference-based generic HRQoL instruments

15D and EQ-5D results in patients with metastatic prostate cancer

Source: Torvinen et al. Acta Oncol 2013

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Change in the 15D score, 0-12 months (M16.0 or M16.1 and NFB30), n=292/614

75% of the patients regard their HRQoL as improved after the intervention.

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Change in 15D score (0-12 months), n=740

MID (Minimad important difference) ± 0.015 21.10.2015

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The 15D-profiles of septoplasty patients before and after operation 1,00

15D score Before 0.949 After 0.928 p